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Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)

Sponsor
Indiana University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04930055
Collaborator
(none)
220
Enrollment
2
Locations
26.2
Anticipated Duration (Months)
110
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goals of this study are to assess initial or booster vaccine performance (safety and efficacy) and to collect serum and peripheral blood mononuclear cells (PBMCs) pre and post-vaccination to assess immune and other response parameters following immunization in cancer patients receiving either the Pfizer (BTN162b2), Moderna (mRNA-1273), or the Janssen (Ad26.COV2.S) vaccines under the FDA Emergency Use Authorization (as per the decision of their treating physician judgment and standard of care)

Condition or Disease Intervention/Treatment Phase
  • Biological: COVID-19 Vaccination

Study Design

Study Type:
Observational
Anticipated Enrollment :
220 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Immune Responses in Oncology Patients to Novel Coronavirus Vaccines (IROC)
Actual Study Start Date :
Jun 4, 2021
Anticipated Primary Completion Date :
Aug 11, 2023
Anticipated Study Completion Date :
Aug 11, 2023

Arms and Interventions

Arm Intervention/Treatment
Group 1

Patients with solid tumors receiving courses of cytotoxic therapy.

Biological: COVID-19 Vaccination
Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 2

    Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 3

    Patients with solid tumors receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 4

    Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 5

    Patients receiving immune checkpoint inhibitors.

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 6

    Patients who underwent allogeneic stem cell transplant within 12 months.

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 7

    Patients who underwent cellular therapy, including CAR-T cells or T cells with engineered TCRs within 12 months.

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 8

    Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 9

    Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 10

    Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 11

    Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•
    Group 12

    Patients who have a cancer diagnosis but do not fall into group 1-11

    Biological: COVID-19 Vaccination
    Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
    Other Names:
  • Moderna (mRNA-1273)
  • Pfizer (BTN162b2)
  • Janssen (Ad26.COV2.S)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Event Collection [from date of vaccination until 2 months after full vaccination]

    Secondary Outcome Measures

    1. Incidence of COVID-19 infection [from date of vaccination until 6 months after full vaccination]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Ability to provide written informed consent and HIPAA authorization

    2. Patients deemed eligible and willing to receive a COVID-19 vaccine by treating physician per standard of care.

    3. Subjects must be ≥ 18 years old at the time of consent.

    4. Diagnosis of cancer and fall into one of the groups below:

    5. Group 1: Patients with solid tumors receiving courses of cytotoxic therapy.

    6. Group 2: Patients with hematological cancers receiving courses of cytotoxic chemotherapy.

    7. Group 3: Patients with solid tumors receiving tyrosine kinase inhibitors (TKIs) or other targeted therapies, but not cytotoxic regimens within 3 months.

    8. Group 4: Patients with hematologic cancers receiving TKIs or other targeted therapies, but not cytotoxic regimens within 3 months.

    9. Group 5: Patients receiving immune checkpoint inhibitors.

    10. Group 6: Patients who underwent allogeneic stem cell transplant within 12 months.

    11. Group 7: Patients who underwent cellular therapy, including Chimeric antigen receptor t-cells (CAR-T) cells or t-cells with engineered t-cell receptors (TCRs) within 12 months.

    12. Group 8: Patients in remission who have received cellular therapy more than 12 months in the past, including allogeneic, autologous or engineered cellular approaches.

    13. Group 9: Patients with cancer in remission for at least 2 years not receiving active cytotoxic cancer chemotherapy (hormonal therapy is permitted).

    14. Group 10: Patients who have undergone allogenic bone marrow transplant and are currently receiving immunosuppressants

    15. Group 11: Patients who have undergone allogenic bone marrow transplant who are not currently receiving immunosuppressants

    16. Group 12: Patients who have a cancer diagnosis but do not fall into group 1-11

    17. Estimated survival of 8 weeks or more following enrollment on the study.

    Exclusion Criteria:

    1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active COVID-19 infection or influenza-like-illness. If subjects have previously tested positive for COVID-19 infection, they are eligible to participate in this study after 90 days

    2. Unwilling or unable to follow protocol requirements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IU Health Joe and Shelly Schwarz Cancer Center Carmel Indiana United States 46032
    2 Indiana University Melvin and Bren Simon Comprehensive Cancer Center Indianapolis Indiana United States 46202

    Sponsors and Collaborators

    • Indiana University

    Investigators

    • Principal Investigator: Utpal Dave, MD, Indiana University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Utpal P. Davé, Associate Professor Department of Medicine Division of Hematology/Oncology, Indiana University
    ClinicalTrials.gov Identifier:
    NCT04930055
    Other Study ID Numbers:
    • CTO-IUSCCC-0759
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Aug 4, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Utpal P. Davé, Associate Professor Department of Medicine Division of Hematology/Oncology, Indiana University
    COVID-19
    Vaccine
    Pfizer
    Moderna
    Janssen
    COVID
    Additional relevant MeSH terms:
    Coronavirus Infections

    Study Results

    No Results Posted as of Aug 4, 2022